MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11500A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Insufficient Information (4580)

Event Date 01/03/2024

Event Type  Injury  

Event Description

Through implant patient registry it was learned a 19mm 11500a aortic valve was explanted after implant duration of three (3) years, 10 months, due to unknown reasons.The explanted device was replaced with a 21mm 11060a aortic valved conduit.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional customer complaint.The information reported may or may not be related to the edwards device.

Manufacturer Narrative

The device was not returned to edwards for evaluation.Attempts to retrieve the device and additional information is in process.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.Attempts to retrieve additional information were unsuccessful.The cause of the event cannot be determined.

Event Description

Through implant patient registry it was learned a 19mm 11500a aortic valve in aortic position was explanted after implant duration of three (3) years, 10 months, and 18 days due prosthetic valve stenosis secondary to infective endocarditis.The explanted device was replaced with a 21mm 11060a aortic valved conduit.Per medical records the patient initially presented with right sided weakness concerning for cva, and diarrhea.Workup revealed ct of head negative, no acute neurological process, pneumonia, possible peri-annular abscess, severe stenosis, moderate mr, and possible pvl.The patient was hospitalized for approximately three weeks, treated and sent home on antibiotics.Two weeks later the patient was admitted with fever chills, confused with delirium, paraplegia of the rue, hr in the 40s and diagnosed with sepsis and infective endocarditis.A tee showed rocking of the aortic valve, severe as and mobile mass in the ventricular side consistent with vegetation, aortic annular abscess, and moderate regurgitation, cath showed no significant cad.The 19mm 11500a valve was found to be heavily calcified at surgery, there was noted to be a large abscess involving the annulus of the aortic valve and the entire right coronary sinus and right coronary ostia.Due to large amount of inflammation it was impossible to mobilise the left coronary ostia for subsequent anastomosis to the hemashield graft.The patient underwent an aortic root replacement using a 21 mm 11060a and reimplantation of the right coronary ostia and bypass to the obtuse marginal and right coronary artery using reverse autogenous saphenous vein and cabg to the anterior descending using the lima.The aortic cross clamp was removed and there was brisk hemorrhage from the distal suture line of the graft and the ascending aorta.Cpb was resumed and an anastomosis repair performed with a separate piece of 21mm graft.The patient was briefly weaned from cpb, however, the left and right ventricles were profoundly hypokinetic, the patient underwent further complex coronary bypass using internal mammary segments in an effort to supply blood flow to the lv.A tee showed excellent left ventricular and right ventricular function.The patient was weaned from cpb.After closing the chest and then removing the drapes , the endotracheal tube was noted to be malposition which resulted in profound hypoxemia due to inadequate ventilation and subsequent cardiac arrest.The sternum was reopened, the patient re-cannulated and placed back on cpb.Attempts to discontinue bypass were only marginally successful and the patient was placed on ecmo and transferred to a higher level of care.At time of transfer the patient was stable on vasopressin and levophed.Pathology: aortic valve- fibrin with dense acute and chronic inflammation.

Manufacturer Narrative

Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18822876
• MDR Text Key: 336733524
• Report Number: 2015691-2024-01545
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194968
• UDI-Public: (01)00690103194968(17)240820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 04/11/2024
• Supplement Dates FDA Received: 04/12/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male